Diane Keyser

Diane Keyser

Senior Quality Engineer

 

Diane has over 30 years’ broad experience in the development of medical devices, encompassing early-stage concept through high volume manufacturing with start-up through Fortune 500 companies.  As both an individual contributor and a manager of teams of engineers, she has worked on hundreds of products that aim to provide solutions to previously unmet needs.  As a quality professional, she was directly responsible for the development and  maintenance of a Quality Management System (QMS) from the ground up.  She appreciates the importance of robust design control and risk management documentation to support regulatory submissions.  Diane holds a MS in Mechanical Engineering from Stanford University and BS in Mechanical Engineering from MIT.  She is a certified ISO 13485:2016 Lead Auditor.

Diane enjoys:

  • Kayaking and hiking
  • Practicing and teaching Yoga
  • Listening to live music
  • Traveling the world